Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

Eligibility Criteria

• 1. Provision of written informed consent/assent.
• 2. Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
• 3. Diagnosis of HAE-1/2/3.
• 4. History of at least 2 HAE attacks in the last 3 months before screening.
• 5. Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
• 6. Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose and regimen and intend to remain on the same dose for 6 months before screening and the duration of the study. OR, Participant has stopped using plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat) at least 2 weeks or lanadelumab at least 10 weeks before screening.
• 7. Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device.
• 8. For adolescent participants aged ≥12 and \<18 years of age: body weight ≥40 kg.
• 9. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.
• 1. Any female who is pregnant, plans to become pregnant, or is breastfeeding.
• 2. Any diagnosis of angioedema other than HAE.
• 3. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
• 4. Use of attenuated androgens for short-term prophylaxis within 2 weeks before screening.
• 5. Abnormal hepatic function.
• 6. Abnormal renal function (eGFR \<60 ml/min/1.73 m2).
• 7. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
• 8. Has received prior on-demand HAE treatment with deucrictibant.
• 9. Currently participating in any other investigational drug study or receiving other investigational treatment within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
• 10. Prior gene therapy for any indication at any time.
• 11. Use of concomitant medications with systemic absorption that are strong inhibitors of CYP3A4 or strong inducers of CYP3A4 within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
• 12. Known hypersensitivity to study drug or any of the excipients of study drug.